SubscribeThis training course on pharmacokinetics (PK) in drug development explores the principles behind pharmacodynamics and pharmacokinetic modelling.
The days when pharmacokinetics (PK) involved a sharpened pencil and semi-log graph paper are long gone. Advances in computer technology and analysis software have brought the science to the forefront of drug development. The number of candidate drugs failing in man due to poor PK properties has fallen due to a better understanding of this area. In development an understanding of the relationship between PK and pharmacodynamics (PD; efficacy and toxicity) is required.
Variability in PK due to factors such as demography and pharmacogenetics can influence the PKPD relationship to the extent that a dose adjustment is necessary to maintain therapeutic benefit. Mathematical modelling techniques such as population pharmacokinetics have enabled such information to be more readily extracted from clinical trial data. Regulatory authorities see the importance of PK & PD and consequently there are several guidances devoted to this area. An integrated approach to PK from pre-clinical through to development and beyond is therefore recommended.
Pharmacokinetics and Drug Development Strategy
Further your understanding of pharmacokinetics and enhance your drug development strategy with this course
Attendance at this course will ensure you will gain a better understanding of the principles of pharmacokinetics (PK) and of pharmacokinetic/pharmacodynamic (PKPD) modelling and how regulatory guidances influence PK strategy in drug development
What is PK and why is it important?
- Absorption, distribution, metabolism and elimination (ADME)
- Drug failures
- Therapeutic windows
Pre-Clinical / Clinical Interface
- What PK data are available, how does this influence the Clinical PK strategy?
- Biomarkers
- Implications for CTA- dose choice and dose escalation in First Time In Man (FTIM), adaptive dosing
Variability in Pharmacokinetics
- Factors affecting variability
- Drug interactions; CYPs and transporters strategies and regulatory guidance; types of interaction competitive vs mechanism based; implications for study design (restrictions healthy volunteers vs patients etc)
PK PD Modelling and Simulation in Drug Development
- What is PK PD modelling, why do it
- The regulatory environment
Route of administration
- Oral versus inhaled
- Regulatory guidance
Course Speaker
Dr Graham Blakey, GBPK Consulting. A well qualified speaker with extensive experience in Clinical Pharmacokinetics. Graham has had a long career in industry from Principal Scientist to Head of Clinical Pharmacokinetics. He is experienced in pharmacokinetic/pharmacodynamic (PK/PD) analysis, early phase drug development, clinical pharmacology strategy, drug interactions and regulatory submissions.
This course is organised by PharmaTraining Services.
Complete details are available on our website.